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NCT03767595

ProACT Post-Approval Study

Recruiting now NA Last updated 29 November 2024
What this trial tests

NA trial testing ProACT Adjustable Continence Therapy for Men in Stress Urinary Incontinence in 145 participants. Currently enrolling.

Timeline
19 February 2019
Primary endpoint
1 September 2025
1 September 2030

Quick facts

Lead sponsorUromedica
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment145
Start date19 February 2019
Primary completion1 September 2025
Estimated completion1 September 2030
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Uromedica

Who can join

50 and older, male only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Stress Urinary Incontinence

Currently open trials in the same condition.

Other Uromedica trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03767595.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing